P1023 Clinical study of composite sophora colon-soluble capsules combined with vedolizumab in the treatment of Ulcerative Colitis

Abstract Background There are limited data on the treatment of ulcerative colitis(UC) with in combination with Chinese herbs.The aim of our study was to determine the effectivenes and safety of Vedolizumab combined with Composite Sophora Colon-soluble Capsules(CSCC) use in ulcerative colitis. Methods We identified patients with ulcerative colitis who received CSCC and(or) Vedolizumab between 2021 and 2024 and divided them into the Vedolizumab + CSCC and the Vedolizumab group.The primary end-point was efficacy, based on improvements in inflammatory markers, clinical and endoscopic response.The secondary end-point was safety. Results Of the 31 patients receiving combination therapy there were significantly more patients had a 14-week clinical response and clinical remission compared with patients receiving Vedolizumab alone (74% vs 43%,P=0.036;21% vs 0, P=0.045) ;Significantly more patients responded clinically and endoscopically at 54 weeks (95% vs 68%, P=0.026;76% vs 42%, P=0.028).The difference of C-reactive protein decreased significantly at week 0 compared with week 2, 6, 14 and 54 after treatment (all P <0.05).There were no serious adverse events or deaths. Conclusion Vedolizumab combined with CSCC appears to be an effective option for the patients with UC that is inadequately controlled by Vedolizumab alone.Large prospective studies are needed to confirm these findings.